N-Nitroso Metformin: Synthesis Attempts and Failure Report (NAP Test)

N-Nitroso Metformin is a derivative of the biguanide antihyperglycemic agent Metformin, containing an N-nitroso functional group that raises potential concerns about nitrosamine formation in the presence of nitrosating agents under acidic, neutral, or mildly basic conditions.

EMA Guidance on Nitrosamines

According to EMA guidelines, if repeated synthesis attempts fail to detect the formation of nitrosamine impurities, it is likely that the impurity either does not exist or poses an extremely low risk.

Nitrosation

We conducted multiple nitrosation assays under rigorous forced conditions (NAP tests), to evaluate the risk of N-Nitroso Metformin formation. Our findings revealed that N-Nitroso Metformin does not readily undergo nitrosation under the expected conditions, significantly reducing concerns about its potential formation.

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Our synthesis failure report provides a detailed account of the findings from our synthesis attempts and rigorous testing, demonstrating the non-formation of the nitroso impurity. It offers a comprehensive overview of the evaluated conditions and the resulting data.

N-Nitroso Metformin Technical Information

• Molecular Weight: 158.16 g/mol
• Molecular Formula: C4H10N6O
• IUPAC Name: 1-carbamimidoyl-3,3-dimethyl-1-nitrosoguanidine
• CAS Number: N/A
• Synonyms: N/A

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